Quality by Design (QBD) Approach to Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Esomeprazole and Naproxen in Tablet Dosage Form

The present work describes the development and validation of a new, specific, accurate and precise stability indicating RP-HPLC method for the simultaneous estimation of esomeprazole (ESP) and naproxen (NAP) in modified release tablet dosage form. Analytical Quality by Design (AQbD) concept was implemented through the method development exercise to establish the robustness of the method. Method development was performed on C18, 250 × 4.6 mm ID, and 5 μm particle size column, and injection volume was 10 μL using a photo diode array (PDA) detector to monitor the detection at 280 nm. The mobile phase consisted of buffer: methanol at a ratio of 50: 50 (v/v), and the flow rate was maintained at 1.5 mL/min and the column oven temperature was maintained at 30⁰C. The method was validated in terms of system suitability, specificity, accuracy, linearity, precision and solution stability. Linearity was observed over the range of concentration 10-12 μg/mL for ESP and 200-300 μg/mL for NAP, and the correlation coefficient (R²) was found to be excellent >0.999. The method was specific with respect to esomeprazole and naproxen, and the peak purity was found 99.93% for ESP and 100.00% for NAP. The method was precise and had %RSD less than 2. Recovery study for accuracy with placebo was found in the range of 99.63% to 100.36 % for ESP and 99.91% to 100.43% for NAP. This proposed fast, reliable, cost-effective method can be used as quality control tool for simultaneous determination of esomeprazole and naproxen in routine laboratory analysis.